Bulk Pharmaceutical API Sources for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Bulk Pharmaceutical API Sources for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemShuttle		139096
DC Chemicals		DC10369
BLD Pharm		BD626471
AbMole Bioscience		M9020

Bulk Active Pharmaceutical Ingredient (API) Sources for Tipiracil Hydrochloride and Trifluridine

Last updated: November 15, 2025

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Overview of Tipiracil Hydrochloride and Trifluridine

Tipiracil hydrochloride and trifluridine are critical components of chemotherapeutic regimens, notably in combination therapies for cancer treatment. Tipiracil hydrochloride functions as a thymidine phosphorylase inhibitor, enhancing the bioavailability of trifluridine, a nucleoside metabolic analog with cytotoxic activity. Their combined formulations are marketed as Lonsurf (tips in colorectal and gastric cancers). Securing high-quality bulk APIs is vital for pharmaceutical manufacturing, especially given regulatory and efficacy considerations.

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Api Market Landscape and Supply Chain Dynamics

The antibiotic and antiviral/antineoplastic API markets are characterized by tightly controlled supply chains due to the complexity of synthesis, stringent quality standards, and patent protections. Despite their niche applications, specialized suppliers dominate these markets.

Sources for Tipiracil Hydrochloride and Trifluridine are limited, typically concentrating in regions with advanced pharmaceutical manufacturing capabilities, mainly in Europe, North America, and parts of Asia.

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Bulk API Sources for Tipiracil Hydrochloride

Manufacturers and Suppliers

1. Jubilant Life Sciences (India)

   • Profile: A prominent integrated pharmaceutical company with extensive experience in nucleoside APIs.
   • Capabilities: Produces tipiracil hydrochloride at commercial scale, adhering to cGMP standards.
   • Quality Assurance: Certificates of Analysis (CoA), stability data, and regulatory approvals consistent with international standards.
   • Supply Focus: Contract manufacturing and bulk supply for generics and proprietary formulations.

2. Shaanxi Tianxing Pharmaceutical (China)

   • Profile: Specialized in nucleoside analogs, with recent expansion into complex APIs.
   • Capabilities: Offers tipiracil hydrochloride API with competitive pricing.
   • Market Position: Noted for flexible production quantities suitable for both clinical and commercial use.

3. Fresenius Kabi (Germany)

   • Profile: Global leader manufacturing sterile and non-sterile APIs.
   • Capabilities: Certified manufacturing processes for nucleoside derivatives, including tipiracil hydrochloride.
   • Distribution: Well-established global distribution network, compliant with EMA and FDA standards.

4. Lonza Group (Switzerland)

   • Profile: Provides custom synthesis of high-value APIs.
   • Capabilities: Capable of manufacturing tipiracil hydrochloride on a large scale with strict quality controls.

Emerging and Smaller Suppliers

• Several smaller Chinese and Indian API manufacturers are increasingly offering tipiracil hydrochloride, often catering to specific regional markets or serving as secondary suppliers. Their regulatory compliance and quality certifications vary, necessitating thorough due diligence.

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Bulk API Sources for Trifluridine

Leading Suppliers

1. Molekula (UK)

   • Profile: A specialized API manufacturer with extensive experience in antiviral and antineoplastic APIs.
   • Product Focus: Supplies high-purity trifluridine suitable for clinical and commercial applications.
   • Regulatory Status: Compliant with EC and FDA standards; certified batch manufacturing.

2. Taj Pharmaceuticals (India)

   • Profile: An established producer of nucleoside APIs.
   • Capabilities: Offers bulk trifluridine, supported by rigorous quality control and competitive pricing.
   • Market Role: Frequently supplies to Asian markets and third-party manufacturers.

3. WUXI APPTEC (China)

   • Profile: An integrated contract development and manufacturing organization (CDMO) with global reach.
   • Capabilities: Manufactures trifluridine at scale, with extensive development and approval support.

4. Pfizer (USA)

   • Profile: Historically a key supplier of nucleoside analogs, including trifluridine for specific formulations.
   • Market Status: May have transitioned manufacturing focus, but legacy supply channels remain.

Additional Suppliers

• Other Chinese and Indian API producers, such as Hikal and Zhejiang Hisun Pharmaceutical, provide bulk trifluridine. Their production capacities are expanding, but regulatory and quality controls require verification.

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Quality and Regulatory Considerations

Suppliers must demonstrate compliance with cGMP, with detailed documentation, stability testing, and analytical validation. Companies should verify:

• Batch-to-batch consistency
• Validation and certification (e.g., EMA, FDA, ICH guidelines)
• Material safety data sheets (MSDS)
• Certificates of Analysis (CoA)

Regions like Europe and North America impose stricter oversight, but reputable Asian suppliers increasingly meet these standards, particularly for export to regulated markets.

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Supply Reliability and Risk Factors

• Regulatory risk: Suppliers must maintain valid manufacturing licenses and registration statuses.
• Market volatility: API prices fluctuate owing to raw material costs, regulatory changes, and patent expirations.
• Manufacturing capacity: Limited high-volume suppliers may impact long-term production planning.
• Quality assurance: Verify the supplier’s compliance with analytical testing standards and quality assurance protocols.

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Emerging Trends in API Sourcing

The increasing demand for complex APIs like tipiracil hydrochloride and trifluridine spurs investments in CDMOs and API manufacturing hubs in Asia. Additionally, the adoption of API sourcing transparency initiatives aims to increase supply chain reliability and compliance.

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Key Takeaways

• Market Concentration: Tipiracil hydrochloride and trifluridine sources are concentrated among a handful of validated global suppliers, predominantly in India, China, Europe, and the U.S.
• Quality Assurance Priority: Rigorous supplier qualification, including audits and documentation review, is essential to ensure regulatory compliance and product efficacy.
• Supply Chain Risks: Manufacturers should diversify supplier bases to mitigate disruptions and ensure uninterrupted API supply.
• Regulatory Compliance: Sourcing from suppliers with verified GMP certifications and consistent regulatory track records improves risk mitigation.
• Emerging Supply Chains: Asian API manufacturers are increasingly credible, offering competitive pricing and reliable quality for both clinical and commercial manufacturing.

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FAQs

Q1: What regulatory standards should I verify before sourcing tipiracil hydrochloride or trifluridine APIs?
A1: Ensure suppliers comply with cGMP, with proper documentation aligned with FDA, EMA, or ICH guidelines. Certificates of Analysis, stability data, and licensing are critical.

Q2: Are Chinese and Indian suppliers reliable for high-quality APIs?
A2: Many are capable of producing high-quality APIs that meet international standards, especially if they possess recognized certifications. Due diligence and supplier audits are recommended.

Q3: How does supply chain diversification benefit pharmaceutical manufacturing?
A3: It reduces dependency on a single supplier, minimizing risks related to production delays, regulatory issues, or raw material shortages.

Q4: Can emerging Asian suppliers meet European and US regulatory standards?
A4: Yes. Many Asian API manufacturers have achieved certifications and quality controls that meet or exceed international standards. Verification and audits are advisable.

Q5: What are key considerations when transitioning API sources?
A5: Evaluate quality consistency, regulatory approvals, manufacturing capacity, lead times, and logistics. Pilot batch testing is recommended before full-scale manufacturing.

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Sources:

[1] Pharmaceuticals and Healthcare Reports, Global API Market Analysis, 2022.
[2] Sourcing Guidelines for Active Pharmaceutical Ingredients, World Health Organization, 2021.
[3] Regulatory Affairs and API Certification Standards, FDA and EMA Documentation, 2022.
[4] Company Websites and Public Disclosures from Jubilant Life Sciences, Shaanxi Tianxing Pharma, Fresenius Kabi, Lonza, Molekula, and others.